Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07276867
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).'}], 'secondaryOutcomes': [{'measure': 'Total amount of morphine', 'timeFrame': '24 hours postoperatively', 'description': 'If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg.'}, {'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperatively', 'description': 'Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure is elevated more than 20% of the baseline (after exclusion of other causes than pain).'}, {'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at the Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 18, and 24 h postoperatively.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrathecal', 'Dexmedetomidine', 'Fentanyl', 'Bupivacaine', 'Spinal Anesthesia', 'Above Knee Amputation', 'Sarcomas', 'Lower Extremity']}, 'descriptionModule': {'briefSummary': 'The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.', 'detailedDescription': 'Above-knee amputation (AKA) for advanced lower limb (LL) sarcomas has a high risk of chronic pain syndromes, like phantom limb pain, and is associated with severe perioperative pain. Effective analgesia is essential for patient comfort, early rehabilitation, and improved outcomes.\n\nDexmedetomidine (DEX), a highly selective α2-adrenergic agonist, is a promising intrathecal (IT) adjuvant.\n\nThe combination of DEX and fentanyl may produce synergistic effects, extending block duration and improving perioperative analgesia while minimizing individual drug doses. The current approach is particularly relevant in oncologic surgeries like AKA, where optimal pain control is critical. However, supportive evidence exists in various surgical contexts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 60 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status of II-III.\n* Height between 150-185 cm.\n* Body mass index between 18-35 kg/m².\n* Scheduled for above-knee amputation due to lower limb sarcomas.\n\nExclusion Criteria:\n\n* Allergy to any of the investigated drugs.\n* History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.\n* Contraindications to spinal anesthesia.\n* Pregnancy or lactation.\n* Presence of psychiatric illness or chronic pain conditions.'}, 'identificationModule': {'nctId': 'NCT07276867', 'briefTitle': 'Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity: A Randomized, Comparative Study', 'orgStudyIdInfo': {'id': 'AP2509-501-125-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group DF', 'description': 'Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.', 'interventionNames': ['Drug: Fentanyl + Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group F', 'description': 'Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl + Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.', 'armGroupLabels': ['Group DF']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.', 'armGroupLabels': ['Group F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mai M Elrawas, MD', 'role': 'CONTACT', 'email': 'mai.elrawas@nci.cu.edu.eg', 'phone': '00201222177242'}, {'name': 'Mohamed A Wadod, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Doaa A Abdou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mai M Elrawas, MD', 'role': 'CONTACT', 'email': 'mai.elrawas@nci.cu.edu.eg', 'phone': '00201222177242'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.', 'investigatorFullName': 'Mai Mohamed El Rawas', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}